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FDA 510(k)

THE Graft Collagen

K-Number: K230305 · 2024-07-24

ApplicantPurgo Biologics, Inc.
Decision Date2024-07-24
Product CodeNPM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THE Graft Collagen is a medical device manufactured by Purgo Biologics, Inc.. It received FDA 510(k) clearance on 2024-07-24 under approval number K230305. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE Graft Collagen?

THE Graft Collagen is a medical device that received FDA 510(k) clearance on 2024-07-24. It is manufactured by Purgo Biologics, Inc.. The 510(k) number is K230305.

When was THE Graft Collagen approved by the FDA?

THE Graft Collagen received FDA 510(k) clearance on 2024-07-24, under approval number K230305.

What company makes THE Graft Collagen?

THE Graft Collagen is manufactured by Purgo Biologics, Inc..

What is the FDA product code for THE Graft Collagen?

The FDA product code for THE Graft Collagen is NPM.

Related Clinical Trials

NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT06335628 Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix RECRUITING NCT07409571 Palatal Wound Healing After Free Gingival Graft Surgery RECRUITING NCT07595198 Platelet-Rich Fibrin (PRF) vs Bone Graft With Membrane for Ridge Preservation After Tooth Extraction NOT_YET_RECRUITING NCT07580495 Effect of Collagen Membrane on Ridge Preservation NOT_YET_RECRUITING NCT07185191 Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS) RECRUITING

Other Devices by Purgo Biologics, Inc.

K173188The Graft Natural Bone Substitute K180992Biotex K191737The Graft Bone Substitute K230091THE Cover K222549OpenTex

Related Devices (Code: NPM)

K151542A-OssHiossen, Inc. K171008Anorganic Bone Mineral with Collagen in Delivery ApplicatorCollagen Matrix, Inc. K163714OSSIX BONEDatum Dental, Ltd. K170541Anorganic Bone Mineral in Delivery ApplicatorCollagen Matrix, Inc. K170245DSM Biomedical Dental Bone GraftKensey Nash Corporation Dba Dsm Biomedical K162158Porcine Anorganic Bone Mineral in Delivery ApplicatorCollagen Matrix, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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